Recall Z-0948-2023
Stradis Healthcare · initiated December 15, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Codes / lots: Assembly Number VCP16515-1, UDI-DI: M765VCP1651511, Lot Number: 221925083
Reason for recall
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
FDA-determined cause: Process control
Action taken
Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
Details
- Recall number
- Z-0948-2023
- Initiated
- December 15, 2022
- Posted by FDA
- January 11, 2023
- Product code
- OWL – Peripheral Catheter Insertion Kit
- Quantity
- 200 units
- Distribution
- US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
- Recalling firm
- Stradis Healthcare, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0931-2023 Class II | Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0932-2023 Class II | PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0933-2023 Class II | Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0934-2023 Class II | Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0935-2023 Class II | PICC KIT, 10/CS, ACCESS MEDICAL LABELPotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0936-2023 Class II | HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE.…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0937-2023 Class II | HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0938-2023 Class II | HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0939-2023 Class II | HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0940-2023 Class II | HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care TechnologyPotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0941-2023 Class II | HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care TechnologyPotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0942-2023 Class II | Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0943-2023 Class II | McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0944-2023 Class II | Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0945-2023 Class II | Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case.…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0946-2023 Class II | Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |
| Z-0947-2023 Class II | Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | 12/15/2022Open, Classified |